Trial · NCT07891286
Mirdametinib to Reduce the Size of Large/Giant Congenital Melanocytic Nevi in Children, Adolescents and Young Adults
NCT07891286, Phase 2, Not yet recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mirdametinib to Reduce the Size of Large/Giant Congenital Melanocytic Nevi in Children, Adolescents and Young Adults. Trials, record NCT07891286. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07891286
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mirdametinib to Reduce the Size of Large/Giant Congenital Melanocytic Nevi in Children, Adolescents and Young Adults
- NCT number
- NCT07891286
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 15 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- LGCMN, Large and Giant Congenital Melanocytic Nevi, NF1, Solid Tumor, Pediatric Tumors, Neurocutaneous Melanocytosis, Congenital Melanocytic Nevus, Arachnoid Cysts, Astrocytoma, Ependymoma, Melanoma
- Interventions
- Mirdametinib
- First posted
- 2026-10-23
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine whether treatment with mirdametinib results in objective decreases in the largest diameter of LGCMN | Pre-treatment and for up to 24 months on treatment. | Difference between the diameter (largest dimension) of the LGCMN recorded during the 24-cycle study period). The average difference, as well as the 95% confidence interval, the median, and the interquartile range, will be reported. The difference will be tested for statistical significance using a paired t-test; with adjustments for distribution, if needed. |
| Secondary | Feasibility of evaluating LGCMN thickness by MRI | Pre-treatment and for up to 24 months on treatment. | The percent of participants with measurable LGCMN thickness (\>1 cm) on MRI will be reported as a summary statistic. |
| Secondary | Determine whether mirdametinib treatment reduces the number of satellite nevi (nevi in addition to the largest target nevus) when they are present | Pre-treatment and for up to 24 months on treatment. | Participants with satellite nevi, in addition to the sentinel LGCMN required for study enrollment, will undergo standardized counting of the satellite nevi. The percentage of participants with satellite nevi at baseline will be reported as a summary statistic. For participants with satellite nevi at baseline, the average and 95% confidence interval of the number of satellite nevi at baseline and at the end of treatment, as well as the median and interquartile range, will be reported. |
| Secondary | Evaluate the safety of mirdametinib in participants with LGCMN | Pre-treatment and for up to 24 months on treatment, including post-safety follow-up. | Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade per CTCAE. |
| Secondary | Determine whether mirdametinib treatment results in improvement of itching QOL measures in participants with LGCMN | Pre-treatment and for up to 24 months on treatment/end of treatment. | The average scores as well as the 95% confidence interval will be reported. |
| Secondary | Evaluate the feasibility of evaluating pERK as a pharmacodynamic marker for mirdametinib response in serial biopsies of LGCMN | Pre-treatment, cycles 2 and 13 on treatment, and end of treatment. | The reported endpoints will be the percentage of participants undergoing at least 2 biopsies and the percentage of biopsies for which pERK was able to be determined via Luminex assay. These will be reported as endpoint/summary statistics. |
| Secondary | Determine whether cutaneous or extracutaneous melanoma occurs in participants with LGCMN while on or after mirdametinib treatment | Pre-treatment and for up to 24 months on treatment, including through up to 5 years of post-treatment follow-up. | The reported endpoint will be the incidence of melanoma for participants on this study. This will be accomplished by calculating the proportion of participants enrolled who are diagnosed with melanoma over the course of the study. Results will be provided on a descriptive basis. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07891286
GET https://conductscience.org/api/trials/v1/NCT07891286/registered